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A Comparison of Two Daily Disposable Contact Lenses
This study has been terminated.
First Received: February 28, 2008   Last Updated: March 13, 2008   History of Changes
Sponsors and Collaborators: Vistakon
Visioncare Research Ltd.
Information provided by: Vistakon
ClinicalTrials.gov Identifier: NCT00634101
  Purpose

This study seeks to evaluate the clinical performance of a new CE marked daily disposable contact lens that contains a wetting agent to a recently improved daily disposable contact lens.


Condition Intervention
Refractive Error
Myopia
Device: nelfilcon A
Device: narafilcon A

MedlinePlus related topics: Eye Wear Refractive Errors
Drug Information available for: Nelfilcon A
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment
Official Title: The Comparative Clinical Performance of Narafilcon A and the FOCUS DAILIES AquaComfort Plus Lens

Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Patient-reported comfort [ Time Frame: Measured at baseline and after 1 week of wear. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measured limbal hyperemia [ Time Frame: Measured at baseline and after 1 week of wear. ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: January 2008
Estimated Study Completion Date: April 2008
Estimated Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
nelfilcon A
Device: nelfilcon A
contact lens
2: Experimental
narafilcon A
Device: narafilcon A
contact lens

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. They are of legal age (18 years) and capacity to volunteer.
  2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
  3. They are willing and able to follow the protocol.
  4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
  5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
  6. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
  7. They have successfully worn contact lenses within six months of starting the study.

Exclusion Criteria:

  1. They have an ocular disorder which would normally contra-indicate contact lens wear.
  2. They have a systemic disorder which would normally contra-indicate contact lens wear.
  3. They are using any topical medication such as eye drops or ointment.
  4. They are aphakic.
  5. They have had corneal refractive surgery.
  6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
  7. They are pregnant or lactating.
  8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
  9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
  10. They have diabetes.
  11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634101

Locations
United Kingdom
Viewpoint
York, United Kingdom, YO1 8BA
United Kingdom, Bedfordshire
Simon Donne Opticians
Bedford, Bedfordshire, United Kingdom, MK40 1NS
United Kingdom, Bristol
Brock & Houlford
Brislington, Bristol, United Kingdom, BS4 3LJ
United Kingdom, Dorset
Keith Tempany Opticians
Broadstone, Dorset, United Kingdom, BH18 8DH
United Kingdom, Essex
Cole Martin Tregaskis Optometrists
Brentwood, Essex, United Kingdom, CM15 8AG
Eyecare
Ilford, Essex, United Kingdom, IG1 4DU
Specsavers Opticians
Colchester, Essex, United Kingdom, CO1 1LJ
United Kingdom, Hants
Cameron-Davies Optometrists
Southsea, Hants, United Kingdom, PO5 2AT
United Kingdom, Herts
Leightons Opticians
St. Albans, Herts, United Kingdom, AL1 3LH
United Kingdom, Isle of Wight
Hazel Smith Opticians
Shanklin, Isle of Wight, United Kingdom, PO37 6JZ
United Kingdom, Lancashire
David Gould Opticians
Rawtenstall, Lancashire, United Kingdom, BB4 7QN
United Kingdom, London
David H. Burns, BSC, FCOptom
Tottenham, London, United Kingdom, N17 0EY
City Opticians
Holborn, London, United Kingdom, WC2A 1AA
Vision Express Optical Lab
Hendon, London, United Kingdom, NW4 3FB
United Kingdom, Middlesex
First Contact Opticians
Pinner, Middlesex, United Kingdom, HA5 1RJ
S.H. Harrold
Uxbridge, Middlesex, United Kingdom, UB81JX
United Kingdom, Norfolk
Dipple & Conway Opticians
Norwich, Norfolk, United Kingdom, NR2 1PB
United Kingdom, Northamptonhsire
Tompkins Knight & Son
Northampton, Northamptonhsire, United Kingdom, NN2 7BL
United Kingdom, South Glamorgan
Chalmers & Sons (Opticians)
Cardiff, South Glamorgan, United Kingdom, CF24 3RQ
United Kingdom, West Midlands
Boots Opticians Ltd
Birmingham, West Midlands, United Kingdom, B4 7TB
Sponsors and Collaborators
Vistakon
Visioncare Research Ltd.
  More Information

No publications provided

Responsible Party: Vistakon, Division of Johnson & Johnson Vision Care, Inc. ( Kurt Moody, OD, FAAO, Associate Director, Clinical Research )
Study ID Numbers: CR-0716, DISP-519
Study First Received: February 28, 2008
Last Updated: March 13, 2008
ClinicalTrials.gov Identifier: NCT00634101     History of Changes
Health Authority: United Kingdom: Research Ethics Committee

Study placed in the following topic categories:
Eye Diseases
Myopia
Refractive Errors

Additional relevant MeSH terms:
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on May 07, 2009